MDCG 2024-5 - guidance on content of the Investigator’s Brochure for clinical investigations of medical devices

The document "MDCG 2024-5" provides detailed guidance on creating an Investigator’s Brochure (IB) for clinical investigations of medical devices under EU Regulation 2017/745 (MDR). The document offers a comprehensive overview for sponsors on how to compile and present necessary information in the IB, ensuring the safety, functionality, and legal compliance of the investigational device.

Here’s a summary of key sections:

1. Introduction: Explains the role of the IB in the documentation required for clinical investigation applications, highlighting its purpose in offering technical and clinical data about the investigational device to sponsors.

2. Content of the Investigator’s Brochure:

• Details on investigational device information such as device identification, intended purpose, clinical performance, and device classification.
• General device descriptions, including design, materials used, and technical specifications.
• Information on labels, instructions for use, and necessary training for device use.
• Pre-clinical evaluation details outlining recommendations and specific tests such as bench testing, reliability, and usability tests.
• Existing clinical data from earlier studies and other relevant investigations.
• Risk management, outlining anticipated serious adverse events and device effects.
• Special considerations for devices that incorporate medicinal substances or are made from human or animal tissues.

3. Appendices: Provide additional reference materials and checklists to aid in the preparation of the IB.

The document emphasizes clarity, completeness, and non-promotional content in the IB to assist competent authorities in assessing the application for a clinical investigation, thus facilitating the review process.

Related standards and guidelines

The document "MDCG 2024-5" references various standards and guidelines to provide a framework for the compilation of the Investigator's Brochure (IB). These standards are crucial for ensuring compliance with regulatory requirements and for guiding the design, evaluation, and documentation of medical devices. Here are the key standards and guidelines referenced:

• ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice.
• EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. This standard helps in assessing the biocompatibility of the device materials.
• IEC 62304:2006 - Medical device software — Software life cycle processes.
• IEC 82304-1:2017 - Health Software — Part 1: General requirements for product safety.
• IEC 60601-1:2005 - Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
• EN ISO 22442-3:2007 - Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents.
• EN ISO 22442-1:2015 - Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management.
• ISO 10993-18 - Chemical characterization of medical device materials within a risk management process.
• ISO 14971:2019 - Application of risk management to medical devices.
• ISO/TR 24971:2020 - Guidance on the application of ISO 14971 to medical devices.

Additionally, the document mentions several European Medical Agency (EMA) guidelines and other regulatory frameworks such as the EU Tissue Directive (2004/23/EC) and the EU Blood Directive (2002/98/EC) which are essential for devices incorporating substances of human or animal origin. These standards provide a detailed methodology for testing, documentation, and quality assurance to ensure the safety and efficacy of medical devices, particularly those involved in clinical investigations.

MDCG 2024-5 vs. ISO 14155

The new aspects introduced in MDCG 2024-5 compared to the ISO 14155 standard mainly involve a focused approach on the Investigator’s Brochure (IB) specific to medical devices, while ISO 14155 provides a broad framework for clinical investigations of medical devices concerning good clinical practice. Here are the notable updates and distinctions:

1. Enhanced Emphasis on Device-Specific Information:

• MDCG 2024-5 places particular emphasis on providing detailed and updated information about the investigational medical device in the IB. This includes descriptions of the device’s design, materials, and operation specific to its intended clinical use.

2. Risk Management and Safety Information:

• The new guideline elaborates on risk management strategies and the importance of outlining potential serious adverse effects and device deficiencies in the IB, a key aspect that complements the safety requirements stated in ISO 14155 but with a more device-centric approach.

3. Special Considerations for Specific Device Categories:

• MDCG 2024-5 includes guidance on special considerations for devices that contain medicinal substances or are derived from human or animal tissues, which are areas not extensively covered by ISO 14155.

4. Pre-Clinical Data Requirements:

• The guidance specifies the need for detailed pre-clinical data including physical, mechanical, and biological testing which must be part of the IB to support the clinical evaluation, echoing the principles of ISO 14155 but with a focus on detailed pre-clinical evaluations pertinent to medical devices.

5. Regulatory and Ethical Considerations:

• While ISO 14155 broadly addresses ethical considerations and regulatory compliance, MDCG 2024-5 ties these requirements specifically to the EU regulatory framework, emphasizing alignment with EU MDR 2017/745 requirements.

MDCG 2024-5 provides specific directives for compiling the IB within the context of the EU's Medical Device Regulation, offering more detailed guidance on what must be included in the IB specific to medical devices compared to the broader strokes of ISO 14155, which applies universally to clinical investigations in medical settings.

We are at your service

European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

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